NCT03833063 (BOTDEP) is a Phase 1 clinical trial of botulinum toxin A in Major Depressive Disorder, sponsored by Helse Stavanger HF.

Who is sponsoring NCT03833063?

NCT03833063 is sponsored by Helse Stavanger HF.

What drugs are being tested in NCT03833063?

Interventions in NCT03833063: botulinum toxin A, Placebos.

What condition does NCT03833063 study?

NCT03833063 studies Major Depressive Disorder, Major Depressive Episode, Treatment Resistant Depression.

Is NCT03833063 still recruiting?

NCT03833063 is currently withdrawn. Last updated 11 August 2021.

Last reviewed 2021-08-11 · How we verify

NCT03833063: BOTDEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

Withdrawn Phase 1 Last updated 11 August 2021

What this trial tests

Phase 1 trial testing botulinum toxin A in Major Depressive Disorder. Withdrawn.

Timeline

1 May 2019

Primary endpoint
31 December 2019

31 March 2020

Quick facts

Lead sponsor	Helse Stavanger HF
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Start date	1 May 2019
Primary completion	31 December 2019
Estimated completion	31 March 2020

Drugs / interventions tested

botulinum toxin A — full drug profile →
Placebos — full drug profile →

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →
Major Depressive Episode — all drugs for Major Depressive Episode →
Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

Helse Stavanger HF — full company profile →

Who can join

Adults 65 to 99, any sex, with Major Depressive Disorder or Major Depressive Episode. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Novel drug developmental strategies for treatment-resistant depression.
Borbély É, Simon M, Fuchs E, Wiborg O, et al · · 2022 · cited 70× · PMID 34822719 · DOI 10.1111/bph.15753
Botulinum Toxin Injections for Psychiatric Disorders: A Systematic Review of the Clinical Trial Landscape.
Demchenko I, Swiderski A, Liu H, Jung H, et al · · 2024 · cited 9× · PMID 38668616 · DOI 10.3390/toxins16040191

Verify or expand the search:

Other trials of botulinum toxin A

Trials testing the same drug.

NCT06218316 — Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral · NA · completed
NCT05296759 — Botulinum Toxin Type A in Diabetic Peripheral Neuropathy · Phase 4 · completed
NCT03187626 — Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis · Phase 2, PHASE3 · completed
NCT03816046 — Hyperhydrosis Treatment Using Botulinum Toxin · Phase 4 · completed
NCT05618470 — Wumeiwan Jiawei Fang Use in Patients With Blepharospasm · Phase 2, PHASE3 · unknown

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Helse Stavanger HF trials

Trials by the same sponsor.

NCT06983002 — Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Dis · NA · not yet recruiting
NCT06774261 — Phenserine on the Alzheimer's Treatment Horizon, Study 1 · Phase 1 · not yet recruiting
NCT06362707 — Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) · Phase 2 · recruiting
NCT06211907 — Small Macular Holes Treated With Air · NA · recruiting
NCT06150274 — Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03833063 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Helse Stavanger HF
Last refreshed: 11 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03833063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing